HPLC-MS/MS method for quantification of paclitaxel from keratin containing samples.
HPLC-MS/MS method for quantification of paclitaxel from keratin containing samples.
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DOI：
10.1016/j.jpba.2017.03.011
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发表时间：
2017-05-30
影响因子：
3.4
通讯作者：
Yazdani SK
中科院分区：
文献类型：
--
作者：
Turner EA;Stenson AC;Yazdani SK
紫杉醇的局部给药变得越来越普遍。随着复杂的药物/辅料组合的开发和测试，需要能够从这些制剂中定量紫杉醇的新的高效液相色谱-质谱仪(HPLC-MS)技术。建立并验证了一种从含水、蛋白质和油脂样品中定量测定紫杉醇的方法。角蛋白来自人的头发，是该方法开发和验证中的蛋白质成分/紫杉醇辅料。这种方法的新颖性是因为它能够克服水溶性问题，并解决临床级紫杉醇注射剂组合物中残留溶剂的清除问题。以叔丁基甲醚和乙醇为萃取剂，其萃取率分别为31.9±2.3%和86.4±4.5%。在蒸发和复水后，样品用高效液相-质谱仪进行评估，并建立了紫杉醇的定量方法。方法的日间精密度为9.1%，日内精密度为4.3%，与多西紫杉醇内标进行归一化处理。所述方法适用于任何含有蛋白质和/或油的紫杉醇水样。
Local drug delivery of paclitaxel is becoming ever more prevalent. As complex drug/excipient combinations are being developed and tested, new high performance liquid chromatography-mass spectrometry (HPLC-MS) techniques capable of quantifying paclitaxel from such formulations are needed. Here a method for quantifying paclitaxel from aqueous, protein and oil containing samples was developed and validated. Keratin, derived from human hair, is the protein component/paclitaxel excipient in the development and validation of said method. The novelty of this method is described by its ability to overcome water solubility issues and address clean-up of residual solvents in clinical grade paclitaxel injection composition. The method evaluates tert-butyl methyl ether and ethanol as extraction solvents with an extraction efficiency of 31.9 ± 2.3% and 86.4 ± 4.5% respectively. Upon evaporation and rehydration, samples were evaluated by HPLC-MS and a method was developed for paclitaxel quantification. The method developed had an inter-day precision of 9.1% relative standard deviation and an intra-day precision of 4.3% relative standard deviation normalized to a docetaxel internal standard. The described method is applicable to any aqueous paclitaxel sample containing protein and/or oils.